Kornimate/medical-research-clean huggingface dataset:
the effect of mesotherapy and intra-articular steroid injection in shoulder pain

Conditions: Chronic Shoulder Pain

Summary: patients with chronic shoulder pain will be divided randomly into mesotherapy and intra-articular steroid injection groups. pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

the study will include 84 patients aged 18-75 who applied to physical medicine and rehabilitation out-patient clinic with chronic shoulder pain between may and july 2024. patients will be randomly divided into two groups: a mesotherapy group and steroid injection group, using the closed-envelope method. in the first group, a total of 3 sessions of mesotherapy are applied to the shoulder areas of the patients, 7 days apart. a single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered for patients in group 2. pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

Eligibility criteria:
inclusion criteria: 1. ages 18-75 2. having shoulder pain for 6 months 3. vas (visual analog scale) \&gt; 4 4. patients who can receive verbal instructions and do not have cognitive deficits exclusion criteria: 1. physical therapy applied to the shoulder area in the last 3 months 2. having had a shoulder joint injection in the last 3 months 3. history of previous upper extremity surgery 4. history of drug allergy 5. use of anticoagulant drugs (warfarin, low molecular weight heparin), patients with coagulation disorder 6. history of malignancy 7. psychiatric illness 8. a rheumatological diagnosis such as polymyalgia rheumatica, rheumatoid arthritis, ankylosing spondylitis 9. kidney failure 10. liver disease 11. heart failure 12. pregnancy 13. presence of infection, wound, allergy, burn-like lesions in the application area

Keywords: shoulder mesotherapy pain steroid injection
dose-finding study of apd403 to prevent nausea and vomiting after chemotherapy

Conditions: CINV

Summary: comparison of efficacy of apd403 at preventing delayed sickness in patients who have received cancer chemotherapy


Eligibility criteria:
inclusion criteria * male or female patients ≥ 18 years of age * ability and willingness to give written informed consent * patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first cisplatin chemotherapy infusion at a dose of ≥70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only) * karnofsky performance score ≥ 60% * adequate cardiac, hepatic and renal function * qtc interval \< 500 ms * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \< 5 x upper limit normal (uln) * bilirubin \< 5 x uln * creatinine \< 3 x uln * adequate haematological function * haemoglobin ≥ 8 g/dl * white blood count ≥ 3.0 x 109/l * platelet count ≥ 100 x 109/l * for females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (iud) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards exclusion criteria * patients scheduled to receive, prior to or in the 120 hours after cisplatin or ac, any other chemotherapeutic agent with a high or moderate emetic risk * patients who have previously received anti-neoplastic chemotherapy * patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy * patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin or ac administration * patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma * patients with a pre-existing vestibular disorder * patients being treated with regular anti-emetic therapy including corticosteroids * patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
comparison between amoxycillin/clavulanic acid and oxacillin/ceftriaxone for community acquired-pneumonia

Conditions: Community-Acquired Pneumonia

Summary: objective: to compare the clinical effectiveness and hospital costs, the initial empirical treatment, oxacillin / ceftriaxone and amoxicillin / clavulanate in children with community acquired pneumonia (cap) severe. methods: clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe cap, according to criteria of world health organization (who), admitted to the pediatrics ward of the hospital of the medical school of botucatu- unesp. we excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. we included 104 children who were randomized into two groups to receive: oxacillin / ceftriaxone iv (gco, n = 48) and amoxicillin / clavulanate iv (gaa, n = 56). patients of the gaa, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the goc received any iv treatment. the outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (dp / e) and hospital costs. treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.

eligibility: children aged two months to five years with diagnosis of severe community acquired pneumonia, requiring hospitalization. outcomes measures: time to clinical improvement (respiratory rate and fever), duration of oxygen therapy, length of stay in the division of pediatrics, evolution with clinical complications, need for broadening the spectrum antimicrobials.

Eligibility criteria:
inclusion criteria: * children aged from 2 months to 5 years * children diagnosed with severe community-acquired pneumonia, who require hospitalization. exclusion criteria: * chronical diseases * severe comorbidities * children admitted at picu

Keywords: pneumonia children antibiotics
reduction of topical anesthetic onset time using ultrasound

Conditions: Pain

Summary: children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (lmx4), or the study intervention which utilizes ultrasound to speed the onset of lmx4 from 30 minutes to 5 minutes. the child's pain with the blood drawing procedure is evaluated.


Eligibility criteria:
inclusion criteria: * ages 3-7, requiring venipuncture exclusion criteria: * emergent procedure * allergy to lidocaine or sodium lauryl sulfate
the role of b cells in kidney allograft dysfunction

Conditions: Kidney; Complications, Allograft; Transplantation Infection

Summary: the purpose of this study is to understand the role of specific b cells in activating or repressing an anti-allograft immune response after kidney transplantation. in this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

the purpose of this study is to understand the role of specific b cells in activating or repressing an anti-allograft immune responses after kidney transplantation. this study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. in this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign the written informed consent form (icf). for pediatric patients, a parent or legal guardian must sign icf * either a kidney or liver transplant patient: 1) on the waitlist or 2) transplanted * healthy volunteer samples collected to use as the control group for statistical validity exclusion criteria: * inability to make all of the required long-term post-transplant visits. * females who are pregnant or nursing a child * liver patients with hepatitis c virus

Keywords: bcells kidney allograft dysfunction antibody mediated rejection
michigan emergency department improvement collaborative (medic) alert; pulmonary embolism (pe)

Conditions: Pulmonary Embolism

Summary: this study is a quality improvement project to evaluate health care management of pulmonary embolism (pe) patients. the researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

the study team anticipates that there will be 5800 acute pe patients over multiple sites.

Eligibility criteria:
inclusion criteria: * participation in medic collaborative * identified site physician champion * annual volume of acute pe ≥80 (measured in 2022) exclusion criteria: * pediatric-only hospital/ed * no site physician champion identified * annual volume of acute pe \<80 (measured in 2022) * existing formal clinical pathway for outpatient management of low-risk pe

Keywords: emergency department
post-prostatectomy radiation therapy--moderate versus ultra-hypofractionated (also known as stereotactic body radiation therapy [sbrt])

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to compare the quality of life (qol) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy \[sbrt\]) versus the self-reported qol of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).

conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. these treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy \[sbrt\]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.

Eligibility criteria:
inclusion criteria: * men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a psa ≥ 0.1 ng/ml * interval between prostatectomy and planned radiation therapy start date ≥ 6 months * kps ≥ 70 * patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy) * ability to complete the epic-26 quality of life questionnaire * ability to obtain tissue from radical prostatectomy specimen for review by michigan medicine pathology * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * prior history of pelvic radiation therapy * history of moderate/severe or active crohn's disease or ulcerative colitis * history of bladder neck or urethral stricture * evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels * initiation of androgen deprivation therapy with a lhrh / gnrh agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-lhrh / gnrh agonist or antagonist androgen deprivation or anti-androgen therapy * history of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer * any condition that in the opinion of the investigator would preclude participation in this study

Keywords: stereotactic body radiation therapy (sbrt) ultra-hypofractionated radiation therapy post-prostatectomy
effect of music therapy on pain

Conditions: Chronic Pain

Summary: the aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.

the "u" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature. the objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology. during the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. the evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion). the evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.

Eligibility criteria:
inclusion criteria: * have a pain for more than 6 months * pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve) * speak and read french fluently * wrote consent of patients * benefit from the standard treatment : intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request) exclusion criteria: * time of hospitalization \< 8 days * reflex epilepsy history * major insufficiency of auditory function * patient with a strong possibility of not compliance to the protocol or of abandon in the course of study * presence of an illness threatening vital forecast during period envisaged for the study

Keywords: music therapy pain anxiety depression controlled randomized trial
observation of rotation of an intraocular lens

Conditions: Cataract

Summary: the purpose of this study is to assess the axial iol rotation after surgery with an mc 6125 as iol. at the end of surgery the orientation of the iol is documented with a short video clip via the operating microscope unit. follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. rotational stability of the iol is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.


Eligibility criteria:
inclusion criteria: * uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior iol implantation exclusion criteria: * preceding ocular surgery or trauma * recurrent intraocular inflammation of unknown etiology * uncontrolled glaucoma * uncontrolled systemic or ocular disease * blind fellow eye * microphthalmus * corneal abnormality * history of uveitis/iritis * iris neovascularization * pseudoexfoliation * proliferative diabetic retinopathy

Keywords: iol rotation
early mobilization following emergency abdominal surgery

Conditions: Acute High-risk Abdominal Surgery (AHA)

Summary: acute high-risk abdominal surgery (aha) is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. a recent study revealed very low level of physical performance in the first postoperative week in patients undergoing aha. furthermore the included patients who were non-independently mobilized or had low level of 24-hour physical activity more often experienced a pulmonary complication. studies examining the feasibility of early and intensive mobilization are needed, prior to investigating the effect of the intervention in an randomised controlled trial. the purpose of this study is evaluating the feasibility of early and intensive mobilization during the first week postoperatively among patients who receive acute high-risk abdominal surgery (aha). the aim is also to describe physical performance, physical activity, pulmonary function and health-related quality of life, as well as barriers to mobilization following aha surgery.


Eligibility criteria:
inclusion criteria: • patients (18 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery). exclusion criteria: * patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention). * patients not able to give consent to participation in the study within 48 hours after surgery.

Keywords: abdominal surgery early mobilization feasibility
efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add-on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, north and south america, asia and europe. the purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, 18 years or older at the time of signing informed consent * insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and su (metformin 1500 mg or higher or maximum tolerated dose and su half of maximum allowed dose according to national label or higher) for at least 90 days before screening. stable is defined as unchanged medication and unchanged dose * hba1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period * any disorder which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol * treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness * history of chronic or idiopathic acute pancreatitis * screening calcitonin value greater than or equal to 50 ng/l * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2 * severe renal impairment defined as estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula (4 variable version) * acute coronary or cerebrovascular event within 90 days before randomisation * heart failure, new york heart association class iv * known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator * diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
sleep apnea in heart failure with preserved ejection fraction

Conditions: Heart Failure; Obstructive Sleep Apnea

Summary: this is a prospective interventional study to better understand i) the prevalence of obstructive sleep apnea (osa) in heart failure with preserved ejection fraction (hfpef), ii) its hemodynamic correlates, and iii) the impact of intervention with continuous positive airway pressure (cpap) on quality of life.

this is a prospective non-randomized observational study which will recruit patients with gold standard hfpef defined by exercise catheterization or following hf hospitalization. the prevalence of osa will be determined in all hfpef patients at baseline using home sleep apnea testing and all patients will complete the mayo sleep questionnaire. patients with known osa at baseline will also be included only for the baseline assessment to accurately estimate prevalence of osa in gold standard diagnosed hfpef. the subset of initially recruited patients with hfpef who have newly diagnosed osa will be offered and initiated on cpap therapy to treat their underlying osa. repeat evaluation after 3 months of cpap therapy for end point assessment with remote accelerometry (2 weeks prior to study completion), ess and kccq, which will all be identical to baseline measurements.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of hfpef by catheterization with resting pcwp\>15 mmhg or exercise pcwp\>25 mmhg or hospitalization with hfpef * ambulatory (not wheelchair/scooter dependent) * if no known diagnosis of osa, must not be pacemaker dependent with either atrial pacing or vvi without sinus rhythm * if no known diagnosis of osa, must be able to temporarily hold nitrates or alpha channel blockers for home watchpat testing (3 hour washout period) exclusion criteria: * ejection fraction \<40% * obstructive hypertrophic cardiomyopathy * constrictive pericarditis or tamponade * active myocarditis * complex congenital heart disease * other valve disease requiring surgical intervention * terminal illness (other than hf) with expected survival of less than 1 year * inability to comply with planned study procedures * pregnancy or breastfeeding mothers